一项关于大学生运动员和美国军事学院学员脑震荡影响的全国性研究：NCAA-DoD 脑震荡评估、研究和教育 (CARE) 联合会的结构和方法。
A National Study on the Effects of Concussion in Collegiate Athletes and US Military Service Academy Members: The NCAA-DoD Concussion Assessment, Research and Education (CARE) Consortium Structure and Methods.
机构信息
NeuroTrauma Research Laboratory, University of Michigan Injury Center, University of Michigan, 401 Washtenaw Ave, Ann Arbor, MI, 48109, USA.
Departments of Neurosurgery and Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.
出版信息
Sports Med. 2017 Jul;47(7):1437-1451. doi: 10.1007/s40279-017-0707-1.
BACKGROUND
The natural history of mild traumatic brain injury (TBI) or concussion remains poorly defined and no objective biomarker of physiological recovery exists for clinical use. The National Collegiate Athletic Association (NCAA) and the US Department of Defense (DoD) established the Concussion Assessment, Research and Education (CARE) Consortium to study the natural history of clinical and neurobiological recovery after concussion in the service of improved injury prevention, safety and medical care for student-athletes and military personnel.
OBJECTIVES
The objectives of this paper were to (i) describe the background and driving rationale for the CARE Consortium; (ii) outline the infrastructure of the Consortium policies, procedures, and governance; (iii) describe the longitudinal 6-month clinical and neurobiological study methodology; and (iv) characterize special considerations in the design and implementation of a multicenter trial.
METHODS
Beginning Fall 2014, CARE Consortium institutions have recruited and enrolled 23,533 student-athletes and military service academy students (approximately 90% of eligible student-athletes and cadets; 64.6% male, 35.4% female). A total of 1174 concussions have been diagnosed in participating subjects, with both concussion and baseline cases deposited in the Federal Interagency Traumatic Brain Injury Research (FITBIR) database.
CONCLUSIONS
Challenges have included coordinating regulatory issues across civilian and military institutions, operationalizing study procedures, neuroimaging protocol harmonization across sites and platforms, construction and maintenance of a relational database, and data quality and integrity monitoring. The NCAA-DoD CARE Consortium represents a comprehensive investigation of concussion in student-athletes and military service academy students. The richly characterized study sample and multidimensional approach provide an opportunity to advance the field of concussion science, not only among student athletes but in all populations at risk for mild TBI.
背景
轻度创伤性脑损伤（TBI）或脑震荡的自然史仍定义不清，也没有用于临床的生理恢复的客观生物标志物。美国国家大学生体育协会（NCAA）和美国国防部（DoD）成立了脑震荡评估、研究和教育（CARE）联合会，以研究脑震荡后临床和神经生物学恢复的自然史，从而改善对运动员和军人的伤害预防、安全和医疗。
目的
本文的目的是：（i）描述 CARE 联合会的背景和驱动原理；（ii）概述联合会政策、程序和治理结构；（iii）描述 6 个月的纵向临床和神经生物学研究方法；以及（iv）描述多中心试验设计和实施中的特殊考虑因素。
方法
从 2014 年秋季开始，CARE 联合会的机构已经招募并登记了 23533 名大学生运动员和军事院校学生（约占合格运动员和学员的 90%；64.6%为男性，35.4%为女性）。共有 1174 名参与者被诊断患有脑震荡，脑震荡和基线病例均存入联邦机构间创伤性脑损伤研究（FITBIR）数据库。
结论
挑战包括协调平民和军事机构的监管问题、实施研究程序、协调站点和平台的神经影像学协议、构建和维护关系数据库，以及数据质量和完整性监测。NCAA-DoD CARE 联合会代表了对大学生运动员和军事院校学生脑震荡的全面调查。丰富的特征化研究样本和多维方法为推进脑震荡科学领域提供了机会，不仅在运动员中，而且在所有有轻度 TBI 风险的人群中。
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